Computer System Validation (CSV) Engineer , Dallas, TX Job Title: Computer System Validation (CSV) Engineer Location: Dallas, TX Duration: Long-Term Contract Summary Experienced CSV Engineer responsible for ensuring compliance, data integrity, and validation of computerized systems in regulated environments. The role focuses on maintaining GxP, FDA, and EMA compliance while supporting system qualification and lifecycle activities. Key Responsibilities Develop and execute CSV deliverables per GAMP 5 and ALCOA+ principles. Ensure compliance with data integrity, change control, and deviation management. Author and execute Validation Plans, Risk Assessments, IQ/OQ/PQ, and Summary Reports. Collaborate with Quality, IT, and Engineering teams for system validation and audits. Support lifecycle management and system upgrades. Qualifications Bachelor's degree in Engineering, Computer Science, or related field. 5+ years of CSV experience in pharma, biotech, or medical device industries. Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+. Experience with systems like LIMS, MES, ERP, and SCADA. Excellent documentation and communication skills. Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Information Technology Industries: Professional Services #J-18808-Ljbffr Gandiv Insights LLC
...Epic Travel Staffing is hiring a Travel RN - ER Shift : Nights / 7p-7:30a, 12x3, 36hrs per week,with 30-minute unpaid break,every other weekend required,no call Length : 8 weeks Requirements: ~ NY License ~2 Years Experience ~ AHA BLS ~ AHA ACLS...
Position Requirements 1. Possessing outstanding management experience in the hotel industry, familiar with the entire process of hotel operation, market development, and financial management. 2. Excellent leadership and decision-making skills, capable of leading...
...Job Title: Senior Specialty Physician Coder Location: Remote Duration: 3+ Months (Possibility of conversion into FT) Job... ...years experience working in a hospital or physicians office as a medical coder and interacting with physicians. 1 years experience...
...An industry leading multi-disciplinary team is looking for a Traffic Engineer/Project Manager for their Columbus, Ohio team!... ...projects Develop traffic improvement solutions Perform traffic control studies/designs (all aspects including lane/roadway reconfiguration...
...States and represents the largest public infrastructure project in the history of Hawaii. This position serves as Director of Government Relations and Public Involvement for HART. The Director shapeslegislative and administrative policies and guides all...